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- Experts call for modernizing rare disease evidence models using FDA plausible mechanism frameworkA recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
- FDA expands TEMPO pilot with new digital health partners Limbic, Cadence and DexcomThe FDA is quietly building a pilot program called TEMPO to test a “try first, evaluate later” approach for digital health devices. The agency has added the behavioral‑health firm Limbic to the ro…